Healthy SubjectsPhase 1NCT06548906
A Study of GZR4 Injection at Different Injection Sites
A Phase 1 study testing GZR4 Injection in people with Healthy Subjects, run by Gan and Lee Pharmaceuticals, USA at 1 site in China.
Trial summary
This trial is conducted in China. This study is a randomized, single-center, open, three-period crossover trial in healthy subjects to compare the PK, PD, and safety of a single administration of GZR4 at different injection sites (abdomen, deltoid region of upper arm, and thigh). Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- GZR4 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 8 May 2024to 31 Aug 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Signing the informed consent form (ICF) before the trial, fully understanding the trial content, process and possible adverse reactions, and being able to comply with the contraindications and restrictions specified in this protocol.
- 2. A Male adult subjects aged 18-55 years old.
- 3. Body mass index (BMI) between 19.0-24.0 kg/m2
Who cannot join
- 1. Known or suspected hypersensitivity to investigational medical product(s) or related products.
- 2. Participation in a clinical study of another study drug within 3 months prior to randomization.
- 3. Physical examination, vital signs, laboratory examination, imaging examination, 12-lead electrocardiogram and other auxiliary examination results that the researchers considered abnormal clinical significance during screening.
- 4. Donation of blood or blood products (more than 100mL) or significant blood loss (more than 200 mL) within 6 months prior to screening
- 5. More than 14 units of alcohol per week within 3 months prior to randomization
- 6. Smoking more than 5 cigarettes per day within 3 months prior to randomization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Trial Investigating the Pharmacokinetics, Pharmacodynamics and Safety of GZR4 Injection at Different Injection Regions in Healthy Subjects
This trial is conducted in China. This study is a randomized, single-center, open, three-period crossover trial in healthy subjects to compare the PK, PD, and safety of a single administration of GZR4 at different injection sites (abdomen, deltoid region of upper arm, and thigh).
- Conditions
- Healthy Subjects
- Being tested
- GZR4 Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GZR4 InjectionDrug
GZR4 Injection administered sc, once weekly.
| Study group | Role | What they receive |
|---|---|---|
| GZR4 Injection- Abdomen | Experimental | Participants received GZR4 Injection by subcutaneous injection on Abdomen. Receives: Drug: GZR4 Injection |
| GZR4 Injection- Upper Arm | Experimental | Participants received GZR4 Injection by subcutaneous injection on Upper Arm. Receives: Drug: GZR4 Injection |
| GZR4 Injection- Thigh | Experimental | Participants received GZR4 Injection by subcutaneous injection on Thigh. Receives: Drug: GZR4 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-672h
Area Under the Concentration Versus Time Curve of GZR4 Injection From Time Zero to 672 hours
Measured: From Predose to 672 hours after a single dose
Secondary outcomes (2)
AUC0-∞
Area Under the Concentration Versus Time Curve of GZR4 Injection From Time Zero to Infinity
Measured: From Predose to 672 hours after a single dose
Cmax
Maximum Concentration of GZR4 Injection
Measured: From Predose to 672 hours after a single dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start8 May 2024
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gan and Lee Pharmaceuticals, USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency, Study director, Gan & Lee Pharmaceuticals.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06548906
- Sponsor's protocol ID
- GZR4-T2D-103
- Status last verified
- Aug 2024
- First submitted
- 8 Aug 2024
- Last updated
- 12 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial Investigating the Pharmacokinetics, Pharmacodynamics and Safety of GZR4 Injection at Different Injection Regions in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06548906
- Acronym / sponsor ID
- GZR4-T2D-103
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Gan and Lee Pharmaceuticals, USAIndustry (pharma, biotech, devices)
- Study start
- 8 May 2024 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 12 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is conducted in China. This study is a randomized, single-center, open, three-period crossover trial in healthy subjects to compare the PK, PD, and safety of a single administration of GZR4 at different injection sites (abdomen, deltoid region of upper arm, and thigh).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GZR4 Injection- Abdomen | Experimental | Drug: GZR4 InjectionParticipants received GZR4 Injection by subcutaneous injection on Abdomen. |
| GZR4 Injection- Upper Arm | Experimental | Drug: GZR4 InjectionParticipants received GZR4 Injection by subcutaneous injection on Upper Arm. |
| GZR4 Injection- Thigh | Experimental | Drug: GZR4 InjectionParticipants received GZR4 Injection by subcutaneous injection on Thigh. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 1. Signing the informed consent form (ICF) before the trial, fully understanding the trial content, process and possible adverse reactions, and being able to comply with the contraindications and restrictions specified in this protocol.
- 2. A Male adult subjects aged 18-55 years old.
- 3. Body mass index (BMI) between 19.0-24.0 kg/m2
Key exclusion criteria (6 listed)
- 1. Known or suspected hypersensitivity to investigational medical product(s) or related products.
- 2. Participation in a clinical study of another study drug within 3 months prior to randomization.
- 3. Physical examination, vital signs, laboratory examination, imaging examination, 12-lead electrocardiogram and other auxiliary examination results that the researchers considered abnormal clinical significance during screening.
- 4. Donation of blood or blood products (more than 100mL) or significant blood loss (more than 200 mL) within 6 months prior to screening
- 5. More than 14 units of alcohol per week within 3 months prior to randomization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GZR4 InjectionGZR4 Injection administered sc, once weekly. | Drug | GZR4 Injection- Abdomen, GZR4 Injection- Thigh, GZR4 Injection- Upper Arm |
Primary outcome
AUC0-672h
Time frame: From Predose to 672 hours after a single dose
Area Under the Concentration Versus Time Curve of GZR4 Injection From Time Zero to 672 hours
2 secondary outcomes
AUC0-∞
Time frame: From Predose to 672 hours after a single dose
Cmax
Time frame: From Predose to 672 hours after a single dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Transparency study director
Gan & Lee Pharmaceuticals.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GZR4 Injection in people with Healthy Subjects, run by Gan and Lee Pharmaceuticals, USA at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact wei zhao, PhD (01056456746, wei.zhao@ganlee.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC0-672h (time frame: From Predose to 672 hours after a single dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2024.